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Validation Engineer
Eingestellt von Optimus Search
Gesuchte Skills: Engineering, Engineer, Client
Projektbeschreibung
VALIDATION ENGINEER - SWITZERLAND - 6 MONTH CONTRACT - €80 PER HOUR
Optimus Life Sciences are working with a medical device company in Switzerland. My client is seeking a validation engineer to carry out the qualification and validation of equipment and systems and also to assist in the selection, design and negotiation for equipment. The role involves QA testing and executing validation duties.
RESPONSIBILITIES:
- Plans, develops, and implements documentation and procedures, necessary for the engineering team.
- Generation and execution of validation plans, validation protocols (IQ/OQ/PQ/CSV's), and completion reports. Provide statistical analysis of the date to support the reports.
- Develop statistically based sampling plans for in-process and final testing and inspections, and validations
- Review and approve validations and completion reports for new and existing products, processes and equipment.
- Troubleshooting equipment/processes that do not perform as intended during validation runs.
- Recommend process/quality improvements as part of validation runs.
- Work with new and existing equipment, processes, utilities, facilities and cleaning validations.
- Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
- Complete CAPA investigations and prepare investigation reports.
REQUIREMENTS:
- Lean/Six Sigma Green or Black Belt Certification is a plus.
- Experience in validations such as: manufacturing equipment for medical device companies.
- Minimum of 5 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least 5 years in a validation engineering position.
- Knowledge in Collagen and Silicone technologies and materials.
- Knowledge of FDA, GMP's and ISO requirements.
- Strong Project Management skills.
Optimus Life Sciences are working with a medical device company in Switzerland. My client is seeking a validation engineer to carry out the qualification and validation of equipment and systems and also to assist in the selection, design and negotiation for equipment. The role involves QA testing and executing validation duties.
RESPONSIBILITIES:
- Plans, develops, and implements documentation and procedures, necessary for the engineering team.
- Generation and execution of validation plans, validation protocols (IQ/OQ/PQ/CSV's), and completion reports. Provide statistical analysis of the date to support the reports.
- Develop statistically based sampling plans for in-process and final testing and inspections, and validations
- Review and approve validations and completion reports for new and existing products, processes and equipment.
- Troubleshooting equipment/processes that do not perform as intended during validation runs.
- Recommend process/quality improvements as part of validation runs.
- Work with new and existing equipment, processes, utilities, facilities and cleaning validations.
- Evaluate, investigate and document non-conformances incidents and/or protocol deviations.
- Complete CAPA investigations and prepare investigation reports.
REQUIREMENTS:
- Lean/Six Sigma Green or Black Belt Certification is a plus.
- Experience in validations such as: manufacturing equipment for medical device companies.
- Minimum of 5 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least 5 years in a validation engineering position.
- Knowledge in Collagen and Silicone technologies and materials.
- Knowledge of FDA, GMP's and ISO requirements.
- Strong Project Management skills.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik